NCT01313819

Brief Summary

Tp determine the effect of IV amantadine on dopaminergic-drug-resistant freezing of gait(FOG)in patients with Parkinson's disease

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

March 10, 2011

Last Update Submit

November 9, 2011

Conditions

Parkinson's DiseaseFreezing of Gait

Keywords

Freezing

Outcome Measures

Primary Outcomes (1)

  • change of FOGQ score

    2 days for each drug

Secondary Outcomes (4)

  • UPDRS and HY stage

    2 days for each drug

  • side effect

    2 days, 2 weeks after discharge

  • Patient global impression

    2 days, 2 weeks after discharge

  • 4*10m walk test

    2 days for each drug

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Give IV amantadine first then IV placebo(normal saline) drug

Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj

Group 2

ACTIVE COMPARATOR

Give IV placebo drug first then IV amantadine

Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj

Interventions

PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml injDRUG

IV amantadine at 200 mg in 500 cm3 of saline solution or normal saline 500 cm3 given over a 3-h period, twice a day for 2 days along with the pre-existing dopaminergic and non-dopaminergic medication

Group 1Group 2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 30-80 years
  • idiopathic Parkinson's disease
  • The patient must be taking optimised levodopa/DDI therapy (based on investigator's judgement) during OPD observation period, though the patient have FOG-Q score ≥ 10 points even though On-state.

You may not qualify if:

  • "Off" freezing:The patient has improved FOG in "On" state
  • clinically significant or unstable medical or surgical condition
  • The patient has Parkinson plus like MSA, PSP, and PPFG, and secondary parkinsonism like NPH, vascular parkinsonism, postencephalitic parkinsonism, CO poisoning.
  • history of seizure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (3)

  • Giladi N, Kao R, Fahn S. Freezing phenomenon in patients with parkinsonian syndromes. Mov Disord. 1997 May;12(3):302-5. doi: 10.1002/mds.870120307.

    PMID: 9159723BACKGROUND

  • Giladi N. Medical treatment of freezing of gait. Mov Disord. 2008;23 Suppl 2:S482-8. doi: 10.1002/mds.21914.

    PMID: 18668620BACKGROUND

  • Kim YE, Yun JY, Yang HJ, Kim HJ, Gu N, Yoon SH, Cho JY, Jeon BS. Intravenous amantadine for freezing of gait resistant to dopaminergic therapy: a randomized, double-blind, placebo-controlled, cross-over clinical trial. PLoS One. 2012;7(11):e48890. doi: 10.1371/journal.pone.0048890. Epub 2012 Nov 19.

    PMID: 23185280DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Beom S Jeon, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beom S Jeon, MD, PhD

CONTACT

82-2-2072-2876brain@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 14, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

KR(1)